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Remote Interlock Connector Requirements for Laser Products

This guidance clarifies the requirements for remote interlock connectors in laser products, specifically addressing whether power cable connections can serve as remote control connectors under 21 CFR 1040.10(f)(3).

  1. Ensure laser products include a dedicated remote control connector separate from power connections
  2. Implement proper prevention of laser and collateral radiation access when connector terminals are not joined
  3. Make the remote control connector clearly identifiable for its purpose
  4. Verify commercial availability of necessary mating plugs for remote interlock connections
  5. Consider providing shorting plugs with the product for when remote control feature is not in use
  6. Document compliance with 21 CFR 1040.10(f)(3) requirements in technical documentation
  7. Include remote control connector specifications in product design requirements

Key Considerations

Safety

  • Primary electrical power cable connectors (for power line mains, battery, or converter box) do not satisfy remote control connector requirements
  • When connector terminals are not electrically joined, all laser and collateral radiation access must be prevented
  • The remote control connector must be a separate, independent performance feature
  • The connector must be readily identifiable for its intended purpose
  • A shorting plug may be supplied to complete the circuit when remote control feature is not in use

Other considerations

  • 21 CFR 1040.10: Performance Standards for Light-Emitting Products

Original guidance

  • Remote Interlock Connector Requirements for Laser Products
  • HTML / PDF
  • Issue date: 1976-10-07
  • Last changed date: 2020-03-16
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products
  • ReguVirta summary file ID: db59a64943b572f2881e914f81436a77
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